Urgent notice on the suspension of medical device imports to Azerbaijan

On June 5, 2024, the website of the Analytical Expertise Center (AEC, the regulatory authority of Azerbaijan for medicines and medical devices) of the Ministry of Health of the Republic of Azerbaijan published a notice to importers about the suspension of document processing for the import of medical devices.

Earlier medical devices in Azerbaijan were not objects of state registration and could be imported and placed on the market without a registration certificate.
Amendments to the Law of the Republic of Azerbaijan “On Medicinal Products” have introduced the procedure for state registration of medical devices in 2023.
For a while regulation on registration was in development.

Due to the anticipated start of the registration process in the near future, the AEC temporarily suspends the submission and assessment of the documents for the import of medical devices, except class I devices, and the verification of whether the product is classified as a medical device.

Notice to importers published on the website of the AEC also contains information that the dates of invoicing and bank payments should not exceed the date of approval of this rule from the day this rule comes into force (i.e., from the moment of its approval). It is not clear, but there is a possibility that only those medical devices can be imported to Azerbaijan without registration, that were invoiced and paid before June 5, 2024.
We have already applied for the clarification from the regulatory authority.

The AEC also informed that two legal acts have already come into force:

  • Decision of the Collegium of the Ministry of Health No. 7 dated May 21, 2024 “Approved List of Medical Devices with High and Medium Risk Levels”;
  • Decision of the Collegium of the Ministry of Health No. 8 dated May 21, 2024 “On the Approval of the Classification of Medical Devices Depending on the Degree of Risk”.

The first document is 925 pages listing medical devices with high and medium risk levels (other than class I).
The second legal act approves some definitions and national rules for the classification of medical devices, medical devices for in-vitro diagnostics, and active implantable medical devices in Azerbaijan.

We expect that new regulations will be published soon, and we will notify that in a separate e-mail.

Cratia professionally performs the registration of medical devices and acts as an Authorized representative in the CIS region. We have deep knowledge of national legislation, the necessary experience and resources. To start cooperation or get a consultation, you can contact us at +380680647831, +442081239125, or via email: info@cratia.ua

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